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Repetitive Trans-cranial Magnetic Stimulation of the Motor Cortex in Fibromyalgia: A Study Evaluating the Clinical Efficiency and the Metabolic Correlate in 18FDG-PET

Repetitive Trans-cranial Magnetic Stimulation of the Motor Cortex in Fibromyalgia: A Prospective Randomized Blinded Placebo-controlled Study Evaluating the Clinical Efficiency and the Metabolic Correlate in 18FDG-PET

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00697398
Enrollment
38
Registered
2008-06-13
Start date
2008-10-31
Completion date
2011-10-31
Last updated
2014-08-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fibromyalgia

Brief summary

Fibromyalgia (FM) syndrome is a chronic pain condition.Repetitive trans-cranial magnetic stimulation (rTMS) was thus suggested in this indication.

Detailed description

We recently demonstrated that these patients exhibit significant perfusion abnormalities in regions of the brain known to be involved in sensory and affective-attentional dimensions of pain processing. These results, in agreement with previous functional magnetic resonance imaging reports, confirm the hypothesis of central sensitization, which provides the rationale for prescription of centrally acting analgesic agents in patients with severe FM.

Interventions

Stimulation to white

Sponsors

Assistance Publique Hopitaux De Marseille
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

Inclusion criteria

* Female or male patient, aged from 18 to 65 years * Patient presenting a primary fibromyalgia answering the criteria of the ACR * At present painful patient with a digital echelle of the briefing inventory bread superior or equal to 4/10 * Patient presenting a stable treatment since at least 1 less

Exclusion criteria

* Patient minor * pregnant woman * women in age to procreate without contraception * patient deprived of freedom further to a court or administrative order * patient presenting a secondary fibromyalgia

Design outcomes

Primary

MeasureTime frame
Analgesic efficiency36 months

Secondary

MeasureTime frame
Additional evaluation of the pain36 months
Evaluation of the quality of life36 months
Evaluation of the tolerance of the treatment36 months

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026